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May 19, 2006

Gardasil recommend for approval

by @ 11:54 am.  Filed under FDA, Pharma News

Yesterday, the FDA Advisory committee for vaccines met and recommended 13-0 to approve Gardasil, Merck’s vaccine against human papillomavirus virus (HPV) which can lead to cervical cancer in women. It is good to see the FDA coming down on the side of good science again and not giving in to political pressure. It is estimated that this vaccine could save many of the almost 300,000 lives of women who die world-wide annually, including 3,500 each year in the US.

One aspect which may limit wide-spread use is the cost estimated to be $300-500 and the fact that it is three shots administered over six months. Merck is seeking approval for use in children as young as 9 whereas the panel recommended children as young as 11. It is important to administer the shots before they are sexually active.

It should be noted that Gardasil does not protect against all forms of HPV, but is effective against the ones primarily responsible for cervical cancer.

Other links:
• Washington Post: FDA Panel Endorses Cervical Cancer Vaccine
• Yahoo Finance: FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of GARDASIL(R), Merck’s Investigational Cervical Cancer Vaccine
Yahoo News results for Gardasil

You can hear more of my comments on Gardasil in the Bicyclemark Audio Communique #128

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Email Ed Vawter



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    List of trade publications for chemistry and pharmaceuticals

    by @ 10:41 am.  Filed under Asides

    Just wanted to let folks know I have a large list of chemistry and pharmaceutical trade publications available on the Internet listed on my site. If anyone knows of ones I’ve missed, let me know and I’ll add them.

    Chemistry and Pharmaceutical Trade Publications

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    Email Ed Vawter



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